HANDPIECE, ELECTRIC DERMATOME
Received Jul 9, 2026
Report 0001526350-2026-00801 · MDR key 25758221
Device
Product problems
- Appropriate Device Problem Term/Code Not Available
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THIS COMPLAINT IS RECORDED BY ZIMMER BIOMET UNDER (B)(4). G2: FOREIGN - EVENT OCCURRED IN SOUTH AFRICA. REVIEW OF THE MOST RECENT REPAIR RECORD IDENTIFIED THE FOLLOWING RELATED REPAIR: THE DEVICE WAS SENT FOR SERVICE AND NOTED WORN COMPONENTS, MOTOR SPEED UNSTABLE. THE RECIPROCATION ARM AND MOTOR WERE REPLACED. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. ABLE TO CONFIRM REPORTED EVENT. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
Description of Event or Problem
IT WAS REPORTED THAT OUTSIDE OF SURGERY, ON AN UNKNOWN DATE, THE DEVICE WAS SENT FOR SERVICE. INVESTIGATION RESULTS INDICATE THAT MOTOR SPEED WAS UNSTABLE. THERE WAS NO PATIENT HARM/INJURY OR SURGICAL DELAY AS THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETED.